MEDLINE INDUSTRIES, LP – Northfield Recall 89795
Description: Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case.
MEDLINE INDUSTRIES, LP – Northfield Recall 89795 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0898-2022 |
Event ID | 89795 |
Event Description | Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/pouch, 35 pouches/box, 8 boxes/case. |
Product Type | Devices |
Distribution | US Nationwide Distribution was made to KY, OK, and TX. There was no foreign/government/military distribution. |
Quantity | 7,800 pouched syringes |
Recall Reason | Sterility failure of the exterior of the syringe which may impact the device's ability to be laid on a sterile field. |
Device Classification | 20220413 |
Device Code Info | Lot #3139133, Exp. 11/01/2022. |
Center Classification Date | 20220408 |
Recall Initiation Date | 20220304 |
Recalling Firm | MEDLINE INDUSTRIES, LP - Northfield |
Initial Notification | Letter |
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